1. Field of the Invention
This invention generally relates to a system and method for cleaning and sterilizing lumen devices and, more particularly, to techniques for cleaning and sterilizing the interior of the lumen devices and connection points.
2. Description of the Related Art
In modern medical practices, it has been a common practice to sterilize medical or surgical instruments used for medical or surgical purposes before each use. It is important that the cleaning and sterilization of such instruments be performed efficiently and quickly without leaving potential occluded areas in the instruments. However, the ever increasing complexity of such instruments requires corresponding modifications in conventional cleaning and sterilization techniques and processes, which makes the cleaning and sterilization related problems one of the critical aspects of such instruments.
This is of particular relevance to the instruments comprising elongated channels, such as endoscopes. A typical endoscope generally includes an elongated tubular body having a distal portion and a proximal portion. The distal portion of the endoscope is generally flexible enough to be inserted into a human or animal body so that a lens at the distal end provides an image of an internal area of the body. An image transmission means, such as fiber optic cables, transmits the image of that location from the distal tip, through the proximal portion, to a point outside of the body where it can be viewed by a surgeon or other user of the endoscope. In addition to the image transmission means, the body of the endoscope generally contains one or more channels having at least two open ends along the endoscope body. These channels define a fluid flow path suitable for passing fluids or possibly introducing instruments into a human body. After each use, it is important that these channels, along with the external surfaces of the endoscope, be carefully washed and sterilized for reasons of sanitation.
In one conventional process, cleaning and sterilization of the channels can be provided by flowing a fluid, such as a cleaning solution, a disinfectant or a sterilant, through these channels. In such processes, one opening of a channel may be connected to a fluid delivery source to facilitate the delivery of the fluid into the channel thereby flowing the fluid through the channel to wash, disinfect and/or sterilize the channel.
In general, a connection between the channel openings and the fluid source is provided through a connector. The connector is attached sealably to one or more channel openings so as to allow fluid communication between the channel and the fluid source. Although this process efficiently treats the channels with a fluid, connection between the connector and the lumen device produces occluded areas at the point of connection where the connector is sealably attached to the lumen device. Thus, since these areas are masked by the connector, the fluid flowing into the channel cannot clean and sterilize the connection surfaces.
Thus, there is a need for a cleaning and/or sterilization process having a connector which can deliver fluid to the interior of lumen devices without creating occluded areas around the connection surfaces.
The aforementioned needs are satisfied by the system of the present embodiment which allows the operator to perform multiple cleaning and sterilization sequences without interrupting the cycle. Specifically, the connector of this embodiment entirely automates the cleaning and sterilization system and provides the benefit of not leaving any occluded area between the connector and the lumen device.
It will be appreciated that there are multiple aspects of the present invention. In one aspect of the present invention, a connector for use with a lumen device that provides fluid communication between a fluid source and the lumen device is provided. The connector is configured to engage with a port on the lumen device wherein the port includes a sealing surface. The term xe2x80x9cpressure actuatedxe2x80x9d as defined in this application is not limited to members actuated by pressure alone but also encompasses actuation with a solenoid, electromagnet, or a pneumatic device. The connector includes a housing defining a space, a pressure actuated member positioned within the space so as to be movable therein, a piston surface formed on the pressure actuated member that engages with the sealing surface of the port of the lumen device. The pressure actuated member defines at least one passageway for the fluid to flow from the fluid source to the lumen device through the connector. Further, the piston surface is less than fully engaged with the sealing surface when the pressure actuated member is in a first position. However, the piston surface fully engages with the sealing surface when the pressure actuated member is in a second position allowing the fluid enter the lumen device.
In another aspect of the present invention, a method for cleaning or sterilizing interior and exterior of a lumen device is provided. The lumen device has a port that is connected to the interior of the lumen device, and the port has a sealing surface. The method includes the following steps. In the first step, a connector device is connected to the port. The connector has a housing and a pressure actuated member which is movably positioned within said housing. Further, the pressure actuated member defines a passageway to allow fluid flow through the connector. In the second step, the connector device and the lumen device are placed in a chamber. However, the first and second steps can be performed in any order. In the third step, the pressure actuated member positioned in a first position in which the connector is connected to the port and the lumen device is subjected to a fluid so that the fluid contacts the sealing surface of the port, and thereby treating the sealing surface with the fluid. In the fourth step, the pressure actuated member is positioned in a second position. When the pressure actuated member is in the second position, a piston surface of the pressure actuated member fully engages with the sealing surface so as to induce the piston surface to seal with the scaling surface thereby allowing the fluid flowing into the interior of the lumen device. The step of positioning the pressure actuated member in a first position and the step of positioning the pressure actuated member in a second position can be performed in either order.
In another aspect of the present invention, a connector for use with a lumen device that provides a sterilization fluid to the lumen device in a sterilization environment is provided. The connector is configured to engage with a port on the lumen device and the port includes a sealing surface. The connector includes a housing that is adapted to receive the port and defines a space, a sterilant enclosure containing a sterilization fluid connected to the space, a pressure actuated member positioned within said space so as to be movable therein, a piston surface formed on the pressure actuated member that engages with the sealing surface of the port of the lumen device. The pressure actuated member defines at least one passageway for sterilization fluid to flow from the sterilant enclosure to the lumen device. Further, the piston surface is less than fully engaged with the sealing surface when the pressure actuated member is in a first position. Moreover, the piston surface fully engages with the sealing surface when the pressure actuated member is in a second position allowing the sterilization fluid from the enclosure enter the lumen device.
In yet another aspect of the present invention, a method for sterilizing interior and exterior of a lumen device is provided. The lumen device has a port that is connected to the interior of the lumen device. Further, the port has a sealing surface. The method includes the following steps. In the first step, a connector device is connected to the port, and to a source of sterilant. The connector device has a housing and a pressure actuated member is movably positioned within the housing. The pressure actuated member defines a passageway to allow sterilant flow through the connector. In the second step, the connector device and the lumen device are placed in a sterilization chamber. However, the first and second steps can be performed in any order. In the third step, the pressure actuated member is positioned in a first position in which the connector is connected to the port and the lumen device is subjected to a sterilant so that the sterilant contacts the sealing surface of the port thereby treating the sealing surface with the sterilant. In the fourth step, the lumen device is subjected to reduced pressure. Finally, in the fifth step, the pressure actuated member is positioned in a second position. When said pressure actuated member is in the second position, a sterilant flows through the path way and a piston surface of the pressure actuated member fully engages with the sealing surface so as to induce the piston surface to seal with the sealing surface thereby allowing the sterilization fluid flowing through the path way to enter the interior of the lumen device. The step of positioning the pressure actuated member in a first position, the step of subjecting the lumen device to reduced pressure and the step of positioning the pressure actuated member in a second position can be performed in any order.
These and other objects and advantages of the present invention will become more fully apparent from the following description taken into conjunction with the accompanying drawings.